Kornimate/medical-research-clean huggingface dataset:
the impact of implementing a nursing-driven clinical pathway for inpatient management of children with asthma

Conditions: Asthma

Summary: asthma is the most common chronic disease of childhood and is responsible for large portion of pediatric admissions to canadian hospitals. there is evidence that clinical pathways allow for optimal delivery of care and may result in decreased length of stay, leading to important economic benefits. weaning of asthma medications prescribed for asthma exacerbation is not standardized in the current model of care. currently, weaning is performed by ward physicians; in a teaching hospital, this most often done by residents staff. differences in practice between different physicians, delays in patient assessment and adjustment of doctor's orders, likely prolong the hospital stay for children admitted with asthma. this study's main objective is to determine the effect of a nursing-driven clinical pathway on children's length of stay when admitted to hospital with a diagnosis of acute asthma exacerbation. the pathway will allow nurses to wean a specific type of medication(β2-agonist), as compared to the current standard of care, which dictates that a physician writes an order to wean the medication. number of administered β2-agonist treatments will be compared between both groups, as well as asthma-related health care utilization within two weeks of hospital discharge. nursing, physician, and patients' satisfaction with the pathway will be evaluated, and a cost minimization analysis will be performed. this study has the potential to improve resource use efficiency, increase patient safety by avoiding administration of unnecessary medications, and ameliorate quality of care by standardizing the care of children admitted to the hospital with a diagnosis of acute asthma exacerbation. the results of the study will be disseminated across the canadian health care system with the goal of improving outcomes of children admitted to hospitals with acute asthma exacerbations.


Eligibility criteria:
inclusion criteria: * children admitted during the study period with a diagnosis of asthma exacerbation, reactive airway disease, or wheezing * children aged 2 to 17 years exclusion criteria: * children under the age of 2 years * children with congenital heart disease * children with chronic lung diseases other than asthma, including cystic fibrosis and bronchopulmonary dysplasia * children with severe neurological impairment * children with other significant co-morbid disorders * children whose caregivers do not understand english or french * children whose caregivers cannot be reached by phone for the 14-day follow up

Keywords: asthma nursing protocol pram length of stay weaning clinical pathway asthma exacerbation
the basophil activation test for egg allergy

Conditions: Food Allergy

Summary: in this study, basophil activation test (bat) established by the investigators' lab was evaluated for its sensitivity and specificity in child egg allergy diagnosis. children with suspected ige mediated allergy to egg will be recruited in the study. specific ige to egg allergen and bat will be detected. the diagnostic accuracy of the bat will be assessed against clinical diagnosis based on history, clinical symptoms and laboratory results.

in china, the prevalence of food allergy in in preschool children was about 7%. diagnosis of food allergy is mainly based on a combination of clinical history, clinical manifestations and related supplementary examinations, including skin prick testing (spt), serum specific ige testing (sige), and oral food challenge (ofc). although ofc is the gold standard for allergy diagnosis, it is rarely conducted in clinic for the low safety. until now, serum specific ige assays against allergen are the most commonly used in vitro diagnostic approach in china. however, specific-iges are sensitive, but not specific for diagnosis of food allergy. moreover, food allergy could not be excluded when sige results are negative (\<0.35ku/l). thus, more accurate and safer test is needed. bat was shown to have good accuracy for food allergy diagnosis. bat is an ex vivo functional assay that measures by flow cytometry the degree of basophil activation after stimulation with an allergen. however, experimental strategies for bat reported in the literatures are different. some research even used 12 kinds of antibodies to identity basophils. in previous study, the investigators established bat using 4 kinds of antibodies. basophils could be distinguished well from other cells. in this study, children aged 4 months to 6 years who visit pediatric and emergency department, and are suspected with egg allergy will be included in study. detailed information about clinical history and manifestations will be collected. serum sige to food and bat will be detected. the proposed study intends to analyze sensitivity and specificity of the established bat according to the clinical comprehensive diagnosis results, and evaluate its efficacy to diagnose food allergy in children.

Eligibility criteria:
* 1.children older than 4 months and younger than 6 years old * 2.suspected egg allergy with one or more of the following complaints after intake of egg: skin or mucous symptoms (e. g. urticaria, increased eczema, or swollen lips) respiratory symptoms (tight throat or shortness of breath with signs of bronchial obstruction) loss of consciousness gastrointestinal symptoms (nausea, vomiting, abdominal pain, diarrhea) ocular symptoms (conjunctival erythema, pruritus, tears) and other related symptoms * 3. sign informed consent by parents/guardians exclusion criteria: * 1.patients with hematological tumors, autoimmune diseases, organ transplantation, and immunodeficiency diseases * 2.take immunosuppressants, immunomodulators, statins, and inject anesthetics within 3 weeks
rheumatoid arthritis response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: observational and prospective study of the ultrasound response to methotrexate in rheumatoid arthritis patients who started methotrexate

* rheumatoid arthritis patients with active disease who start subcutaneous methotrexate by their rheumatologist prescription methotrexate will be included. * patients will participate in a prospective and observational study in which the response to methotrexate will be assessed by ultrasound (us) of joints and tendons. * the main objective of the study is the change in b mode and doppler mode us after 24 weeks of methotrexate treatment.

Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis fulfilling eular criteria. * prescription of methotrexate by a rheumatologist. * informed consent signed by the patient. exclusion criteria: * none
a phase 1b study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of jnj-64565111 in participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this phase 1b study is to assess the safety and tolerability of jnj-64565111 in adult men and women (of non-child bearing potential) with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus (t2dm) at least 3 months prior to screening * hemoglobin a1c (hba1c) greater than or equal to (\>=) 7.0 percent (%) and lesser than or equal to (\<=)9.5% at screening * on a stable treatment regimen for at least 3 months prior to screening of (1) diet and exercise, and/or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg) per day) * body mass index (bmi) ranging from 25 to 40 kilogram per square meter (kg/m\^2) (inclusive), weighing between 75 and 130 kg (inclusive) * a woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hcg) at screening and day -2 * blood pressure (measured after the participant is sitting/ resting quietly for 5 minutes) between 90 and 140 millimeter of mercury (mmhg) systolic, inclusive, and between 60 and 100 mmhg diastolic, inclusive at screening (sitting) and day -2 (supine). if the average of the first triplicate blood pressure assessment is out of range, up to 2 repeated triplicate assessments are permitted exclusion criteria: * history or current diagnosis of acute or chronic pancreatitis * familial or personal history of multiple endocrine neoplasia type 2,familial/non-familial medullary thyroid carcinoma * donated blood or blood products or lost a significant amount of blood (\>500 milliliter \[ml\]) within 3 months before the first administration of study drug * history of hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv) positive, or other clinically active liver disease, or tests positive for hbsag or anti-hcv at screening * history of human immunodeficiency virus (hiv) antibody positive, or tests positive for hiv at screening
initial study of rituximab to treat primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: the purpose of this study is to determine the safety of the anti-cd20 antibody rituximab in treating patients with primary biliary cirrhosis (pbc). rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. rituximab may also help people with pbc, a disease of the immune system. however, the safety of rituximab in pbc patients must first be established.

this is a pilot, open-label, study on 10 female patients with ama-positive pbc to determine the effects of two infusions of rituximab on response of memory b cells to bacterial motifs, on biochemical function, and histological features. we will enroll 10 consecutive ama-positive patients with the diagnosis of pbc based on internationally accepted criteria and histological staging determined at liver biopsy and being currently treated with udca. importantly, patients with advanced histological stages, decompensated liver disease, or waiting for olt will not be included in the study (see exclusion criteria). patients eligible and willing to enter the study will be evaluated at baseline by isolation and study of frequency and absolute numbers of b cells and their function, biochemical and ama tests. histology and quality of life will be also evaluated in all patients. the methodology to be used for b cell study is already well-established in our laboratory as can be seen in the attached paper (kikuchi et al. 2005b). patients will be administered 1,000 mg rituximab intravenously by slow infusion on day 1 and day 15 (+/- 1 day). rituximab's pharmacokinetics indicate that complete b cell depletion is obtained 2-3 days after administration and that such effect may be lost after 9 months (vieira et al. 2004). in addition to our b cell work, serum samples will undergo ama testing, including titers, using recombinant mitochondrial antigens (miyakawa et al. 2001). patients will also undergo serum chemistry panel, which includes liver function tests. patients will continue on a steady dose of udca therapy throughout the study.

Eligibility criteria:
inclusion criteria: * liver biopsy showing histological pbc stages i, ii, or iii * presence of all criteria for the diagnosis of pbc * serum ama at titer \>1:40 * alkaline phosphatase \>2x normal value for \>6 months * compatible liver histology * incomplete response to udca after 6 months of treatment. * negative pregnancy test (female patients in fertile age) * adequate renal function (serum creatinine \< 1.2) exclusion criteria: * end-stage/decompensated liver disease * ascites * jaundice with serum bilirubin \> 2mg/dl * history of digestive bleeding secondary to portal hypertension or endoscopic evidence of varices at stage f2 * history of hepatic encephalopathy * inr\>1.2 * other coexisting causes of liver disease * use of other immunosuppressive medications 4 weeks prior to enrollment * diuretics use

Keywords: primary biliary cirrhosis
a study of pemetrexed plus doxorubicin given to patients with advanced breast cancer

Conditions: Breast Cancer

Summary: this is a non-randomized phase 2 study testing pemetrexed and doxorubicin in combination for locally advanced or metastatic breast cancer. both pemetrexed and doxorubicin have been combined with other drugs, but they have not yet been combined with each other. it is expected that the patient will benefit from the different mechanisms of action of the two drugs. however, there is no guarantee that the patient will benefit from this treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of locally advanced or metastatic breast cancer that is not amenable to local treatment. * patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy. * at least one measurable lesion. * no chemotherapy within 4 weeks prior to enrollment. * signed informed consent from the patient. exclusion criteria: * prior chemotherapy for metastatic breast cancer. * prior treatment with any anthracyclines or anthracenedione-containing regimen. * treatment within the last 30 days with any drug that has not received regulatory approval. * pregnancy and/or breast feeding. * inability or unwillingness to take folic acid or vitamin b12 supplementation.
a trial investigating the influence of oral semaglutide on pharmacokinetics of ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy postmenopausal females

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of the trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy postmenopausal females.


Eligibility criteria:
inclusion criteria: * postmenopausal female, age at least 45 years at the time of signing informed consent. with at least 12 consecutive months since the last spontaneous menstrual bleeding (if there was any uncertainty of the time of the last spontaneous bleeding, the postmenopausal status is to be confirmed with follicle stimulating hormone (fsh) 40 miu/ml) * body mass index (bmi) between 20.0 and 29.9 kg/m\^2 (both inclusive) * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day). a subject smoking less than one cigarette or the equivalent per day must be able or willing to refrain from smoking and use of nicotine substitute products during the trial * any blood draw in excess of 25 ml in the past 30 days, or donation of blood or plasma in excess of 400 ml within the 90 days preceding screening * sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmhg for systolic or 50-89 mmhg for diastolic. if white-coat hypertension is suspected a single repeat measurement is allowed, last measurement being conclusive * history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
use of low sensitivity pregnancy test for self-assessment of medical abortion

Conditions: Completion of Medical Abortion

Summary: the purpose of the study is to design a self-assessment package that could be the preferred option to a follow-up visit at the clinic by the majority of women having early medical abortion.


Eligibility criteria:
inclusion criteria: 1. already be signed up to do a medical abortion at this clinic 2. be willing to come to all clinic appointments and be accessible by phone for 2 weeks after sign up for the study 3. own a cellphone to which will be sent medical abortion-related information and messaging. exclusion criteria: 1. be doing a medical abortion due to failed natural miscarriage 2. not have a working cellphone -

Keywords: feasibility self assessment medical abortion low sensitivity urine pregnancy test south africa
bioabsorbable staple line reinforcement in colorectal,coloanal and ileoanal anastomoses

Conditions: Rectal Cancer; Ulcerative Colitis; Familial Adenomatous Polyposis; Diverticulitis

Summary: the primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.

this is a randomized prospective trial that compares the use of gore seamguard® bioabsorbable staple line reinforcement (cbsg) to standard stapling techniques in colorectal resections. the potential exists to utilize cbsg as a means of lowering the rate of post-operative anastomotic leakage and bleeding in high-risk colorectal, coloanal, and ileoanal anastomoses.

Eligibility criteria:
inclusion criteria: * subjects who will undergo restorative proctectomy or proctocolectomy (\<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis , diverticulitis, perforation of the bowel/trauma. * subjects undergoing hartmann's reversal with restorative proctectomy (\<10 cm from the anal verge). * subjects may or may not have a diverting loop ileostomy as a component of their initial surgery. * subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer. exclusion criteria: * subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease. * subjects who have significant intraoperative hypotension or cardiac events. * subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values).

Keywords: low anterior colon resection proctectomy proctocolectomy anastomosis rectal cancer ileostomy
safety and immunogenicity of high-dose in-b001 in healthy subjects

Conditions: Hand, Foot and Mouth Disease

Summary: this study aims to evaluate the safety and immunogenicity of high-dose in-b001 after administration in healthy subjects

enterovirus 71(ev71) and coxsackievirus a16(cva16) are major causes of hand-foot-and-mouth disease (hfmd) occurring in pediatric population. although ev71 vaccine has been licensed in china, vaccine for cva16-associated hfmd is currently not available anywhere. the purpose of this phase i study is to evaluate the safety and immunogenicity of ev71/cva16 bivalent vaccine in healthy adults.

Eligibility criteria:
inclusion criteria: * healthy adult aged ≥19 to \<50 years at the time of screening tests * body mass index(bmi) of ≥18.0 kg/m2 to ≤27.0 kg/m2, with body weight of ≥55.0 kg to ≤90.0 kg for men and ≥50.0 kg to ≤90.0 kg for women at the time of screening tests * determined by the investigator to be eligible for study participation based on the results of screening tests * intact deltoid muscle that allows administration of the investigational product * consent to use medically acceptable contraception throughout the study * negative finding from a pregnancy test (urine hcg) at the time of the screening for women of childbearing potential * voluntary decision and provision of written consent on participation in this study exclusion criteria: * history of a hand-foot-mouth disease or history of a disease related with enterovirus(ev) infection within 3 months prior to the 1st ip administration * medical history of an anaphylactic or similar acute reaction to in-b001 or similar vaccine * febrile disease or infectious disease within 2 weeks prior to the 1st ip administration * whole blood donation within 2 months or apheresis within 1 month prior to the 1st ip administration * vaccination with other prevention vaccine within 2 months prior to the 1st ip administration * use of an immunomodulator or immunosuppressant within 3 months prior to the 1st ip administration * history of a guillain barre syndrome * excessive caffeine intake or continuous alcohol consumption or incapable of abstention from alcohol during the study * participation in other clinical trial within 6 months prior to the 1st ip administration * pregnant or breastfeeding women * clinically significant hepatic, renal, neurological, respiratory, endocrine, hematology and oncology, cardiovascular, urological or psychiatric disease or such history * positive serological finding (type b hepatitis test, type c hepatitis test, human immunodeficiency virus(hiv) test) * history of drug abuse or positive finding from a urine screening test for an abusive drug * use or of any prescription medication or oriental medicine within 2 weeks or any over-the-counter(otc) medication, health functional food or vitamin within 1 week prior to the 1st ip administration or expected use of such products * administration of a blood product or blood-derived agent within 3 months prior to the 1st ip administration * determined by the investigator to be ineligible for study participation due to other reason including clinical laboratory findings